The initial and ongoing clinical care provided to patients with implantable cardiac device systems often includes the use of programmers. A programmer is a device that enables a clinician to telemetrically communicate with and control an implantable cardiac device such as a pacemaker or defibrillator. Implantable devices often monitor and record a variety of internal physiological parameters of the patient and are often provided with a telemetry system to telemetrically transmit those measured and recorded parameters outside the patient's body to a programmer. A clinician can then review the data via the programmer and make any indicated changes in the patient's therapy.
Implantable devices are also often capable of receiving telemetric signals from a programmer to induce the device to set or change a variety of operational parameters of the device related to the therapy provided by the device as well as to select among the physiological parameters that the device monitors and records. These parameters are often desirably changed during the implantation period to adjust the therapy provided and/or the physiological parameters monitored in order to provide the attending clinician with different information or to adapt the therapy to a more efficacious regimen. It is highly desirable to set these parameters without the expense and health risks to the patient of additional invasive procedures and programmers enable the attending clinician to perform these tasks in a non-invasive, telegraphic manner after implantation with the insight of information provided from internal measurements provided by the device itself.
Accordingly, programmers typically include a display to visually present alphanumeric and graphical information relating to device performance and patient condition as well as user input devices to facilitate data entry and control inputs to be provided by a clinician to control device operation telemetrically. As implantable devices are typically battery powered, thus having also limited electrical power capacity, and, as telemetric communication is a relatively major source of battery depletion, programmers often include a movable wand with an antenna that is placed on the patient overlying the implanted device to receive and send signals to/from the implantable device. The wand is also placed over the implanted device to be proximate the device to thereby limit RF interference with other nearby devices. The telemetry wand with antenna is typically specially adapted for efficient establishment of a telemetric link between the programmer and the implantable device so as to minimize the power that the implantable device must provide to achieve the telemetric link thereby reducing the drain on the battery of the implantable device.
Programmers are particularly useful during the implantation process as the telemetric feedback from the device to the programmer can confirm integrity of the connections of leads to the implantable device as the leads are attached or, conversely, indicate faulty connections thereof. The implantable device can also telemetrically indicate its operational status to the programmer and it will be understood by one of skill in the art that correct device operation is preferably confirmed before closure of surgical incisions.
It will also be appreciated that the actual implantation procedure calls for a sterile environment to reduce risk of infections and complications for the implantee. Thus, it is desirable that not only the implantable device and any leads, but other operating room equipment in contact with the patient, such as a programmer be maintained sterile at least during invasive procedures, such as implantation.
However, it is problematic to sterilize electronic devices, such as programmers, because of their composition and construction. Thus, it is often the practice to interconnect a telemetry wand to the programmer via a relatively long (typically greater than 3 m) cable. The wand and cable are generally encapsulated in such a manner that the wand and cable can be readily sterilized such as by autoclaving or Ethylene Oxide (ETO) gas, without damaging the programmer or requiring that the programmer itself be sterilized. The sterilized wand and cable can then be placed in proximity to the implantee while maintaining an adequate distance from the unsterilized programmer.
However, the distancing between the wand and the programmer also presents some difficulties in use for the clinician. In particular, as previously mentioned, the programmer and wand are a useful tool to the implanting clinician to confirm attachment of leads to the implantable device and to confirm proper device operation and activation prior to closure of surgical incisions. However, the programmer with the display is typically located outside the sterile field and thus outside of the field of view of the implanting clinician. This imposes the burden of providing additional attending staff to convey to the implanting clinician the information provided by the programmer. It can be understood that this presents an added cost and inconvenience and a possible source of error in verbally conveying the information provided in a graphical manner at the programmer.
From the foregoing it can be appreciated that there is an ongoing need for a programmer that provides the ability for a clinician to directly access at least part of the display and control input capability of a programmer from within a sterile field.